Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing (CSTF3PGPSR)
Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A goal of periodontal diagnostic procedure is to provide useful information to the clinician regarding the present periodontal disease type and severity. Advances in diagnostic research are moving towards methods where periodontal risk can be identified and quantified by objective measures such as Biomarkers.
Trefoil factors (TFFs) are one such secreted molecules derived from mucin producing epithelial cells of the gastro intestinal tracts and other tissues such as Salivary glands, Parotid ducts and oral mucosa. Among three Trefoil factors reported, Trefoil Factor 3 (TFF3) is the modifying factor for signalling pathway involved in cell survival, cell proliferation and cell migration of oral keratinocytes. Hence assessing the marker levels would achieve beneficial effects on diagnosing the disease severity.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
For Gingivitis:
- Gingival Index: 1.1 to 2.
- Modifies Plaque Index: 1.0 to 1.9
For Periodontitis:
- Gingival Index: 1.1 to 2.
- Modifies Plaque Index: 1.0 to 1.9
- Probing depth > 4mm
- Clinical attachment loss > 2mm
Exclusion Criteria:
For Gingivitis:
- Presence of gingival recession.
- Presence of clinical attachment loss.
- Presence of furcation.
- Presence of systemic infections like diabetes, infections.
- Smokers.
- Antibiotic therapy received preceding 3 months.
- Patients who underwent periodontal therapy within 3 months.
- Pregnant and Lactating women.
For Periodontitis:
- Presence of any systemic conditions like diabetes, infections.
- Smokers.
- Antibiotic therapy received preceding 3 months.
- Patients who underwent periodontal therapy within 3 months.
- Pregnant and Lactating women.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Experimental: Interventional
Group A patients consists of Gingivitis patients whose serum is collected at base line and treated with Scaling and root planing and after three months serum is collected for assessment of Trefoil factor 3.
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After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.
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Experimental: Experimental Interventional
Group B patients consists of Periodontitis patients whose serum is collected at base line and treated with Scaling and Root Planing and after three months serum is collected for assessment of Trefoil factor 3.
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After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Trefoil factor 3
Periodo de tiempo: 3 months.
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Blood samples were collected by venepuncture of anti-cubital vein.
2ml of blood was collected in each test tube.
10 minutes after collection, the test tube containing 2ml blood was subjected to centrifugation at 3000rpm for 10 min.
The supernatant straw colored fluid (serum) was separated into storage vials (Eppendorf tubes) for serum Trefoil Factor 3.
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3 months.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in the Gingival Index.
Periodo de tiempo: 3 months
|
The severity of gingivitis is scored on all surfaces of selected teeth using Williams Periodontal probe. Index teeth- 16, 12, 24, 36, 32, 44. Score around each tooth is totalled and divided by 4-score of tooth. 0.1-1.0: Mild gingivitis. 1.1-2.0:Moderate gingivitis 2.1-3.0:Severe gingivitis |
3 months
|
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Change in Modified Plaque Index
Periodo de tiempo: 3 months
|
Examination of all the surfaces of the teeth are done using an explorer. The scores for individual teeth may be grouped and totalled and divided by the number of teeth. Excellent:0 Good:0.1-0.9 Fair:1.0-1.9 Poor:2-3 |
3 months
|
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Change in Probing depth
Periodo de tiempo: 3 months
|
The distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.
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3 months
|
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Change in Clinical Attachment loss
Periodo de tiempo: 3 months
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The distance from the cementoenamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.
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3 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Chaiyarit P, Chayasadom A, Wara-Aswapati N, Hormdee D, Sittisomwong S, Nakaresisoon S, Samson MH, Pitiphat W, Giraud AS. Trefoil factors in saliva and gingival tissues of patients with chronic periodontitis. J Periodontol. 2012 Sep;83(9):1129-38. doi: 10.1902/jop.2011.110431. Epub 2011 Dec 19.
- Storesund T, Schreurs O, Messelt EB, Kolltveit KM, Schenck K. Trefoil factor family 3 expression in the oral cavity. Eur J Oral Sci. 2009 Dec;117(6):636-43. doi: 10.1111/j.1600-0722.2009.00679.x.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Panineeya Mahavidyalaya
- D159206045 (Otro identificador: Dr.NTR University of Health Sciences)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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